Osteoarthritis
Conditions
Keywords
Total Hip Replacement
Brief summary
The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and OptiPac/OptiVac bone cement mixing systems.
Detailed description
This is a comparative, prospective randomized Radiostereometry (RSA) study, lead on 48 patients in a single site. All 48 patients will be pooled in a single group for the evaluation of the primary criterion for evaluation, but randomized into four groups for the evaluation of the secondary criteria for evaluation The objectives of the study are to: 1. Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems 2. Measure wear pattern in the cup made of vitamin-E doped polyethylene or conventional Arcom polyethylene 2)Demonstrate non-inferiority of Optipac vs. Optivac cement mixing systems on the stem side 3)Evaluate the clinical outcome and survivorship of the implant
Interventions
DEVICEOptivac
A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results
DEVICEOptipac
A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system
DEVICEArcom (Exceed cup)
The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene
DEVICEE1 (Exceed cup)
The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.
DEVICESirius stem
A polished tapered stem
Sponsors
Zimmer Biomet
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients who are eligible for cemented total hip arthroplasty 2. Patients diagnosed with primary Osteoarthritis 3. Patients who are fit for elective surgery (ASA I - III) 4. Patients with a BMI between 16 and 40 5. Patients who are skeletally mature 6. Patients aged over 18 at the time of surgery 7. Patients willing to return for follow-up evaluations 8. Patients who have the ability to follow instructions 9. Patients with sufficient bone stock and quality
Exclusion criteria
1. Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control) 2. Patients with diagnosed active infection 3. Patients with marked bone loss which could preclude or compromise adequate fixation of the device 4. Patients with Parkinson disease 5. Patients using immunosuppressive drugs 6. Patients with an immunosuppressive disease 7. Patients with BMI \<16 8. Patient with BMI \>40 9. Patients who are unfit for surgery (ASA IV - V) 10. Patients with acetabular or femoral osteotomy 11. Patients who had a THA on the contralateral side within last 6 months 12. Patients belonging to the vulnerable population: children, patients with mental
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiostereometry (RSA) - change in migration and wear over time | First postoperative day, 3 months, 1 year, 2 years and 5 years | Prosthesis migration and cup wear are measured over time, from baseline directly postop up to 5years. Measures are given in change in mm (translation) and degrees (rotation) around x, y and z-axis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm) | First postoperative day, 2 years and 5 years | Signs of radiolucent lines or obvious change of position will be measured in mm |
| HOOS (Hip specific health questionnaire) | Preoperatively, 1 year, 2 years and 5 years | Hip specific health questionnaire - HOOS |
| EQ5D | Preoperatively, 1 year, 2 years and 5 years | General health questionnaire - EQ-5D |
Countries
Sweden
Outcome results
None listed